Multicenter analytical performance evaluation of the ST Genesia thrombin generation system.

Abstract

Available data on the potential use of thrombin generation (TG) assays in clinical practice is promising but larger studies involving several centers are needed to confirm this added-value for clinical purposes. The objective of this evaluation was to assess the analytical performances of the ST Genesia using STG-ThromboScreen, STG-BleedScreen, and STG-DrugScreen reagents across three centers to support its use in multicenter studies. Repeatability and reproducibility have been evaluated using commercial plasmas and quality control (QC) samples. Accuracy was assessed by calculating QC biases from the manufacturer's assigned values. Frozen plasma samples from healthy donors and patients having thrombophilia, hemorrhagic disorders, or taking anticoagulants allowed the comparison of TG parameters between the analyzers from two French centers. Repeatability and reproducibility CVs were respectively below 5% and 10% whatever the reagent and the sample used. The later fell under 6% after normalization. Mean biases between observed and assigned QC values provided by the manufacturer were less than 5% for most TG parameters. We found a good agreement for all TG parameters between the two evaluating centers. Relative bias was below 5% for all combination of parameters and reagents except for Peak height (+14.2%), ETP (+7.3%), and ETP inhibition (-12.0%) using STG-ThromboScreen. We found satisfactory repeatability, reproducibility, accuracy, and inter-laboratory variability for TG parameters using the three available reagents across three centers, supporting the use of ST Genesia in multicenter clinical trials.